Specialist - Extractables and Leachable - MSAT EM

GSK

19d•€70,650 - €117,750

About The Position

The Global Manufacturing Science and Technology (MSAT) organization is a network focused function which provides strategic direction, technical and operations support to ensure that GSK Global Supply Chain network goals and objectives are achieved, through a focused strategy execution. The Senior Specialist – Extractables and Leachable role acts as a global SME support for Large Molecule and Vaccine drug substance and drug product programs for GSK’s External Manufacturing network.

Requirements

Bachelor’s degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related scientific field.
5+ years’ experience in leading E&L assessments.
Experience of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance.

Nice To Haves

Advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline.
Experience working with contract manufacturing organizations (CMOs).
Demonstrated ability to work effectively across a diverse customer base.
Awareness of FDA, US Pharma and Good Manufacturing Practices (GMP) requirements related to packaging.
Ability to work effectively in a matrix organization across geographies and cultures.
Strong verbal and written communication skills.
Prioritization skills.

Responsibilities

Work with internal and external laboratories to ensure E&L testing is completed in a scientific, compliant and cost effective manner.
Conduct and document E&L risk assessments for biopharmaceutical manufacturing processes, container closure systems, and dosing devices.
Deliver key technical information to business partners, to support business decisions and/or regulatory filings.
Manages risk identification and escalation to the GSK stakeholders.
Ensure compliance with external and internal requirements (e.g. GSK QMS, GSK GQSOPs) through interaction with internal organization.